Biografik (Malaysia) Sdn Bhd is one of 141 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Biografik (Malaysia) Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), BG PATIENT EXAMINATION GLOVES, NON-STERILE
2
Total
2
Cleared
0
Denied
Biografik (Malaysia) Sdn Bhd has 2 FDA 510(k) cleared medical devices. Based in Nilai, Negeri Sembilan, MY.
Historical record: 2 cleared submissions from 1996 to 1999. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Biografik (Malaysia) Sdn Bhd Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Biografik (Malaysia) Sdn Bhd
2 devices